# Orthalign, Inc.

- Location (FDA's records): Aliso Viejo, CA
- FDA decisions: 15 (2009–2026): 15 510(k) clearances
- Product codes: OLO (12), ONN (3)
- 510(k) review time since 2016: median 91 days, against 91 for FDA's reviews in the same codes and years (4 of 7 faster)
- Predicates its devices cite: 31 (17 its own); citations of its devices by later devices: 25 (17 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Orthosoft, Inc.: 4 (https://510kreport.com/company/orthosoft)
- Brainlab AG: 4 (https://510kreport.com/company/brainlab)
- Praxim S.A: 2 (https://510kreport.com/company/praxim-s-a)
- Stryker Instruments: 1 (https://510kreport.com/company/stryker-instruments)
- Aesculap Implant Systems, LLC: 1 (https://510kreport.com/company/aesculap-implant-systems)
- Orthosensor, Inc.: 1 (https://510kreport.com/company/orthosensor)
- Gyder Surgical Pty, Ltd.: 1 (https://510kreport.com/company/gyder-surgical)

## Firms that cite its devices most
- Navbit Pty, Ltd.: 1 (https://510kreport.com/company/navbit)
- Zimmer, Inc.: 1 (https://510kreport.com/company/zimmer)
- THINK Surgical, Inc.: 1 (https://510kreport.com/company/think-surgical)
- Insight Medical Systems, Inc.: 1 (https://510kreport.com/company/insight-medical-systems)
- Intellijoint Surgical, Inc.: 1 (https://510kreport.com/company/intellijoint-surgical)
- Orthosensor, Inc.: 1 (https://510kreport.com/company/orthosensor)
- Orthokey Italia S.R.L.: 1 (https://510kreport.com/company/orthokey-italia)
- Gyder Surgical Pty, Ltd.: 1 (https://510kreport.com/company/gyder-surgical)

## Its most-cited devices
- K103829: Kneealign System (2011), cited by 4
- K140331: Orthalign Plus System (2014), cited by 3
- K172462: OrthAlign Plus System (2017), cited by 3
- K171780: OrthAlign Plus System (2017), cited by 3
- K162962: OrthAlign Plus System (2017), cited by 2
- K130387: Orthoalign Plus System (2013), cited by 2

## Recent decisions
- K262253: Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) (Jul 31, 2026)
- K253507: Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee (Jun 2, 2026)
- K242616: Lantern® Hip (Oct 3, 2024)
- K200892: Harvey (R) Surgical Assistant (Jun 18, 2020)
- K200642: OrthAlign Plus System (Apr 10, 2020)
- K172462: OrthAlign Plus System (Nov 22, 2017)
- K171780: OrthAlign Plus System (Jul 11, 2017)
- K163379: KneeAlign 2 System (Mar 2, 2017)

Source page: https://510kreport.com/company/orthalign